Stimulator, Nerve, Transcutaneous, Over-The-Counter
FDA product code NUH · Class II (moderate risk) · 21 CFR 882.5890 · Neurology
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
230510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Everyway Medical Instruments Co.,Ltd 14
- Well-Life Healthcare Limited 11
- Hivox Biotek, Inc. 11
- Shenzhen Osto Technology Company Limited 10
- Shenzhen Kentro Medical Electronics Co., Ltd. 9
- Omron Healthcare, Inc. 7
- Shenzhen Dongdixin Technology Co., Ltd. 6
- Hong Qiangxing (Shenzhen) Electronics Limited 5
- Changsha Yuwen Medical Equipment Co., Ltd. 4
- Shenzhen Jian Feng Electronic Technology Co., Ltd. 4
- Counter Scientific Development (Gz), Ltd. 4
- Shenzhen Jingkehui Electronic Co.., Ltd. 3
- Chongqing Rob Linka Science and Technology Co., Ltd. 3
- Jkh USA, LLC 3
- Tenscare, Ltd. 3
- Hi-Dow International, Inc. 3
- Jkh Health Co., Ltd. 3
- Shenzhen Roundwhale Technology Co. , Ltd. 3
- Newmark, Inc. 3
- Gemore Technology Co, Ltd. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261131 | Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J…NUH · Traditional | Shenzhen Osto Medical Technology Co.,Ltd | 09/06/2026SE |
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H)NUH · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 06/26/2026SE |
| K260425 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)NUH · Traditional | Hivox Biotek, Inc. | 06/16/2026SE |
| K253896 | TENS/EMS device (GUSE01)NUH · Traditional | Globalcare Medical Technology Co., Ltd. | 03/04/2026SE |
| K253305 | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)NUH · Traditional | Shenzhen Jiantuo Electronics Co., Ltd. | 12/31/2025SE |
| K253740 | Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional | Hong Qiangxing (Shenzhen) Electronics Limited | 12/23/2025SE |
| K251958 | VEINOPLUS BackNUH · Traditional | Dynapulse Medical | 12/23/2025SE |
| K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional | Bozhou Rongjian Medical Appliance Co., Ltd. | 11/24/2025SE |
| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special | Everyway Medical Instruments Co.,Ltd | 11/21/2025SE |
| K243131 | Triathlon ProNUH · Traditional | Sigma Biomedical | 11/07/2025SE |
| K251429 | OTC 4-Channel Rechargeable TENS UnitNUH · Special | Changsha Anxiang Medical Technology Co., Ltd. | 08/28/2025SE |
| K250784 | Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/…NUH · Traditional | Shenzhen Yicai Health Technology Co., Ltd. | 08/21/2025SE |
| K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)NUH · Traditional | Changsha Anxiang Medical Technology Co., Ltd. | 07/28/2025SE |
| K243856 | TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)NUH · Traditional | Shenzhen Astec Technology Co., Ltd. | 05/29/2025SE |
| K250360 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)NUH · Traditional | Shenzhen Jiantuo Electronics Co., Ltd. | 05/11/2025SE |
| K250053 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)NUH · Traditional | Shenzhen Jiantuo Electronics Co., Ltd. | 05/09/2025SE |
| K243613 | Patch-TEA (Model TRI-21)NUH · Traditional | Transtimulation Research, Inc. | 04/09/2025SE |
| K250033 | Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)NUH · Traditional | Guangzhou Pinzhi Medical Technology Co., Ltd. | 04/07/2025SE |
| K242460 | Progenix Select StimNUH · Traditional | Progenix, LLC | 04/02/2025SE |
| K242815 | Pocket TENS (EP-300)NUH · Traditional | Hivox Biotek, Inc. | 12/17/2024SE |
| K243334 | Nooro Body & Foot Stimulator (SM9141, SM9142)NUH · Traditional | Xf Agencija Limited | 11/22/2024SE |
| K242332 | Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342…NUH · Traditional | Shenzhen Kentro Medical Electronics Co., Ltd. | 11/05/2024SE |
| K242567 | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS…NUH · Traditional | Changsha Anxiang Medical Technology Co., Ltd. | 11/04/2024SE |
| K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual…NUH · Traditional | Well-Life Healthcare Limited | 10/18/2024SE |
| K241678 | TENS & EMS Stimulator (MHD-1083)NUH · Traditional | Shenzhen Minghuangda Electronics Co., Ltd. | 09/09/2024SE |
| K241365 | Pixie Pulse (SM9068)NUH · Traditional | Pixie Cup, LLC | 08/12/2024SE |
| K241119 | Transcutaneous Electrical Nerve Stimulator (K6106)NUH · Traditional | Shenzhen Yicai Health Technology Co., Ltd. | 07/22/2024SE |
| K233067 | Wireless TENS & EMS (Model SM9110,SM9113,SM9116)NUH · Traditional | Chongqing Rob Linka Science and Technology Co.… | 07/19/2024SE |
| K241509 | TENS&EMS units (SM9109A, SM9109B)NUH · Traditional | Plexus Yoga, LLC Dba Chirp | 06/27/2024SE |
| K231425 | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)NUH · Traditional | Wuxi Jiajian Medical Instrument Co., Ltd. | 03/27/2024SE |
| K240292 | Transcutaneous Electrical Nerve Stimulator (9029SCM)NUH · Traditional | Hong Kong Etech Groups Limited | 03/25/2024SE |
| K232439 | Electrical Stimulator SystemNUH · Traditional | Gymmax Technology Shenzen Co., Ltd. | 03/21/2024SE |
| K233095 | S21 OTC Transcutaneous Electrical Nerve StimulatorNUH · Traditional | Micro Current Technology, Inc. | 03/01/2024SE |
| K231648 | Muscle StimulatorNUH · Traditional | Shenzhen Yiran Intelligent Co., Ltd. | 03/01/2024SE |
| K233784 | ENSO (Model 2)NUH · Traditional | Hinge Health, Inc. | 02/23/2024SE |
| K233092 | Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)NUH · Traditional | Chongqing Rob Linka Science and Technology Co.… | 02/12/2024SE |
| K233040 | EMS/TENS Massager DeviceNUH · Traditional | Shenzhen Imdk Medical Technology Co., Ltd. | 02/12/2024SE |
| K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100…NUH · Traditional | Shenzhen Roundwhale Technology Co. , Ltd. | 01/22/2024SE |
| K233461 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)NUH · Traditional | Hi-Dow International, Inc. | 01/19/2024SE |
| K230926 | Ova+ (K-OVAP-USA)NUH · Traditional | Tenscare, Ltd. | 12/15/2023SE |
| K232517 | Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401…NUH · Traditional | Shenzhen Kentro Medical Electronics Co., Ltd. | 12/08/2023SE |
| K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC)NUH · Traditional | Manamed, Inc. | 11/03/2023SE |
| K232675 | Heating Tens, FT-615NUH · Special | Hivox Biotek, Inc. | 10/05/2023SE |
| K231053 | Unicare (K-UNICARE-USA)NUH · Traditional | Tenscare, Ltd. | 08/18/2023SE |
| K223151 | Nu-beca Transcutaneous Electrical Nerve StimulationNUH · Traditional | Nu-Beca & Maxcellent Co. | 07/19/2023SE |
| K230443 | TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)NUH · Traditional | Jiangxi Royall Smart Technology Co., Ltd. | 05/22/2023SE |
| K223308 | Heating Tens/Ems, FT-810RNUH · Traditional | Hivox Biotek, Inc. | 05/13/2023SE |
| K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012…NUH · Traditional | Shenzhen Kentro Medical Electronics Co., Ltd. | 05/10/2023SE |
| K223825 | Tens & Ems DeviceNUH · Traditional | Shenzhen Jian Feng Electronic Technology Co., Ltd. | 05/09/2023SE |
| K223428 | Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…NUH · Traditional | Shenzhen Leqing Medical Instrument Co., Ltd. | 05/08/2023SE |
| K230829 | TENS7000 Rechargeable (Model:TENS7000 Rechargeable)NUH · Traditional | Chongqing Rob Linka Science and Technology Co.… | 04/26/2023SE |
| K230164 | TENS and EMS Stimulation (OTC)NUH · Traditional | Changsha Yuwen Medical Equipment Co., Ltd. | 04/10/2023SE |
| K230174 | TENS and EMS Stimulation (OTC)NUH · Traditional | Changsha Yuwen Medical Equipment Co., Ltd. | 03/20/2023SE |
| K230163 | TENS and EMS Stimulation (OTC)NUH · Traditional | Changsha Yuwen Medical Equipment Co., Ltd. | 03/20/2023SE |
| K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)NUH · Abbreviated | Andon Health Co, Ltd. | 12/21/2022SE |
| K222488 | Everyway Analog OTC TENSNUH · Traditional | Everyway Medical Instruments Co.,Ltd | 11/15/2022SE |
| K221992 | Electronic Pulse StimulatorNUH · Traditional | Beijing Choice Electronic Technology Co., Ltd. | 10/21/2022SE |
| K221092 | Transcutaneous Electrical Nerve Stimulator Model: ST-304NUH · Traditional | Shenzhen Future Electronic Co., Ltd. | 09/13/2022SE |
| K220997 | Wireless TENS/EMS, Bruno, AelaNUH · Traditional | Zmi Elecronics , Ltd. | 09/01/2022SE |
| K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405NUH · Traditional | Shenzhen Kentro Medical Electronics Co., Ltd. | 08/24/2022SE |
| K220524 | Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)NUH · Traditional | Well-Life Healthcare Limited | 08/04/2022SE |
| K221251 | Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)NUH · Traditional | Guangzhou Huakai Electronic Technology Co., Ltd. | 07/29/2022SE |
| K220573 | NoodleNUH · Traditional | Pourang Bral, Dds, LLC | 07/09/2022SE |
| K221384 | Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2NUH · Special | Hivox Biotek, Inc. | 06/11/2022SE |
| K213788 | TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)NUH · Traditional | Dongguan Bohuikang Technology Co.,Ltd | 05/06/2022SE |
| K220283 | TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)NUH · Traditional | Hong Qiangxing (Shenzhen) Electronics Limited | 05/02/2022SE |
| K220152 | TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)NUH · Traditional | Hong Qiangxing (Shenzhen) Electronics Limited | 04/19/2022SE |
| K212377 | Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01NUH · Traditional | Ningbo Medkinetic Medical Device Co., Ltd. | 04/15/2022SE |
| K220005 | TENS & PMS UnitNUH · Traditional | Shenzhen Yuehua Xinsen Technology Co., Ltd. | 04/01/2022SE |
| K212184 | TENS and EMS Stimulation (OTC)NUH · Traditional | Changsha Yuwen Medical Equipment Co., Ltd. | 04/01/2022SE |
| K213741 | TENS & EMS DEVICE (Model: FM-B2403A)NUH · Traditional | Shenzhen Jian Feng Electronic Technology Co., Ltd. | 03/08/2022SE |
| K213835 | TENS & EMS DeviceNUH · Traditional | Shenzhen Jian Feng Electronic Technology Co., Ltd. | 03/03/2022SE |
| K213091 | Well-Life TENS/EMS/Heating StimulatorNUH · Traditional | Well-Life Healthcare Limited | 02/19/2022SE |
| K220150 | TENS & PMS (Model: SM9126)NUH · Traditional | Hong Qiangxing (Shenzhen) Electronics Limited | 02/17/2022SE |
| K211263 | IntreliefNUH · Traditional | Easymed Instruments Co., Ltd. | 12/30/2021SE |
| K212285 | Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)NUH · Traditional | Oriental Inspiration Limited | 12/22/2021SE |
| K210223 | Transcutaneous Electrical Nerve StimulatorNUH · Traditional | Top-Rank Health Care Co., Ltd. | 12/15/2021SE |
| K212918 | Heat StimPlusNUH · Traditional | Famidoc Technology Co., Ltd. | 12/13/2021SE |
| K212989 | Low-frequency Stimulator (Model: AST-645, AST-646)NUH · Traditional | Shenzhen Osto Technology Co., Ltd. | 11/22/2021SE |
| K202671 | DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)NUH · Traditional | Guangzhou Xinbo Electronic Co., Ltd. | 11/12/2021SE |
| K211403 | HIVOX OTC Electrical Stimulator, FT610-BNUH · Traditional | Hivox Biotek, Inc. | 10/15/2021SE |
| K200558 | Smart Neck StimulatorNUH · Traditional | Guandong Skg Intelligent Technology Co., Ltd. | 10/04/2021SE |
| K211736 | Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V…NUH · Traditional | Shenzhen Osto Technology Company Limited | 09/05/2021SE |
| K210756 | Neck Care Therapy, Model: AST-905A, AST-905D, AST-905HNUH · Traditional | Shenzhen Osto Technology Company Limited | 06/11/2021SE |
| K200694 | Perfect EMSNUH · Traditional | Tenscare, Ltd. | 06/04/2021SE |
| K202866 | TENS & EMS DeviceNUH · Traditional | Shenzhen Jian Feng Electronic Technology Co., Ltd. | 05/19/2021SE |
| K200177 | Low-frequency Multi-function physiotherapy instrumentNUH · Traditional | Shenzhen Kentro Medical Electronics Co., Ltd. | 03/25/2021SE |
| K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2NUH · Traditional | Hivox Biotek, Inc. | 03/10/2021SE |
| K202849 | Everyway Analog OTC TENS, model N103A/N302NUH · Traditional | Everyway Medical Instruments Co.,Ltd | 12/22/2020SE |
| K202470 | Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300NUH · Traditional | Everyway Medical Instruments Co.,Ltd | 11/25/2020SE |
| K202317 | Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806NUH · Traditional | Everyway Medical Instruments Co.,Ltd | 11/13/2020SE |
| K201335 | Li-Battery powered OTC TENS/EMS Combination StimulatorNUH · Traditional | Everyway Medical Instruments Co.,Ltd | 10/24/2020SE |
| K200237 | Transcutaneous Electronic Nerve StimulatorNUH · Traditional | Shenzhen Kentro Medical Electronics Co., Ltd. | 10/19/2020SE |
| K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220…NUH · Traditional | Shenzhen Kentro Medical Electronics Co., Ltd. | 09/25/2020SE |
| K193655 | MSLS6QF TENS/PMS DeviceNUH · Traditional | Self Doctor Care, LLC | 09/04/2020SE |
| K200838 | Tyece OTC TENS ModelNUH · Traditional | Tyece Limited | 08/12/2020SE |
| K200561 | StimPlus Patch, StimPlus Patch, StimPlus PatchNUH · Special | Jkh Health Co., Ltd. | 07/01/2020SE |
| K200354 | Electronic stimulatorNUH · Traditional | Shenzhen Dongjilian Electronics Co., Ltd. | 06/29/2020SE |
| K200727 | TENS and Muscle StimulatorNUH · Traditional | Shenzhen Astec Technology Co., Ltd. | 06/18/2020SE |
| K192201 | Electrical Stimulator SystemNUH · Traditional | Gymmax Technology Shenzen Co., Ltd. | 06/12/2020SE |
| K183110 | LiviaNUH · Traditional | Lifecare , Ltd. | 05/04/2020SE |
| K190783 | Health Expert Electronic Stimulator (model: AST-300L)NUH · Traditional | Shenzhen Osto Technology Company Limited | 03/14/2020SE |
| K192589 | Everyway OTC TENS/EMS CombinationNUH · Traditional | Everyway Medical Instruments Co.,Ltd | 12/19/2019SE |
| K190673 | Health Expert Electronic StimulatorNUH · Traditional | Shenzhen Osto Technology Company Limited | 12/12/2019SE |
| K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)NUH · Traditional | Hong Qiangxing (Shenzhen) Electronics Limited | 12/02/2019SE |
| K191075 | HealyNUH · Traditional | Timewaver Production GmbH | 11/22/2019SE |
| K192087 | Combo Electrotherapy DeviceNUH · Traditional | Shenzhen Roundwhale Technology Co. , Ltd. | 11/01/2019SE |
| K183674 | Electronic Pulse StimulatorNUH · Traditional | Shenzhen Leading Perfection Technology Co., Ltd. | 10/11/2019SE |
| K182136 | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)NUH · Traditional | Shenzhen Osto Technology Co., Ltd. | 10/10/2019SE |
| K182671 | Medi-Direct TENS PenNUH · Traditional | Jkh USA, LLC | 09/21/2019SE |
| K183215 | Focus TENS Therapy, Model PM710-M/-LNUH · Traditional | Omron Healthcare, Inc. | 09/07/2019SE |
| K190988 | GIM-STIM OTC TENS/EMS SystemNUH · Traditional | Gemore Technology Co, Ltd. | 08/16/2019SE |
| K182871 | Mini TENS Therapy DeviceNUH · Traditional | Shenzhen Jumper Medical Equipment Co., Ltd. | 08/01/2019SE |
| K183288 | Transcutaneous Electrical Nerve StimulatorNUH · Traditional | Shenzhen Kentro Medical Electronics Co., Ltd. | 07/30/2019SE |
| K191151 | JKH Stimulator PlusNUH · Special | Jkh USA, LLC | 06/21/2019SE |
| K190115 | MHD TENSNUH · Traditional | Minghuangda Electronic Co., Ltd. | 06/19/2019SE |
| K182108 | Portable Electro-Stimulation Therapy DeviceNUH · Traditional | Guangzhou Longest Science & Technology Co., Ltd. | 04/26/2019SE |
| K190347 | HIVOX OTC Electrical StimulatorNUH · Special | Hivox Biotek, Inc. | 03/15/2019SE |
| K182203 | JKH Stimulator PlusNUH · Traditional | Jkh USA, LLC | 03/14/2019SE |
| K182267 | PAT (Pain Alleviation Technologies)NUH · Traditional | Marchan Medical, LLC | 02/27/2019SE |
| K182120 | Maxpower ReliefNUH · Traditional | Omron Healthcare, Inc. | 01/10/2019SE |
| K172897 | Neck Care Therapy, Model: SYK 509BNUH · Traditional | Shenzhen Osto Technology Co., Ltd. | 12/07/2018SE |
| K172837 | Low-frequency Multi-function physiotherapy instrumentNUH · Traditional | Shenzhen Osto Technology Co., Ltd. | 11/26/2018SE |
| K182581 | PlayMakar Sport Muscle Stimulator, Model PRO-500NUH · Traditional | Playmakar, Inc. | 11/21/2018SE |
| K181992 | Heat Pain ProNUH · Traditional | Omron Healthcare, Inc. | 11/09/2018SE |
| K182767 | V2 OTC Pain Relief TENSNUH · Special | Everyway Medical Instruments Co.,Ltd | 10/26/2018SE |
| K182753 | A6 OTC Pain Relief TENSNUH · Special | Everyway Medical Instruments Co.,Ltd | 10/26/2018SE |
| K181707 | Everyway Wireless TENS & EMS UnitNUH · Traditional | Everyway Medical Instruments Co.,Ltd | 09/26/2018SE |
| K181102 | ThermaCare Quick Therapy TENSNUH · Traditional | Pfizer, Inc. | 09/15/2018SE |
| K172834 | Dual output digital therapy massagerNUH · Traditional | Shenzhen Osto Technology Co., Ltd. | 09/06/2018SE |
| K181849 | iStim S2 OTC Pain Relief TENSNUH · Special | Everyway Medical Instruments Co., Ldt. | 08/10/2018SE |
| K172971 | BMLS16-1NUH · Traditional | Biomedical Life Systems, Inc. | 07/08/2018SE |
| K180331 | Wireless Pain Relieve DeviceNUH · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 06/22/2018SE |
| K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator…NUH · Traditional | Shenzhen Roundwhale Technology Co. , Ltd. | 06/07/2018SE |
| K181207 | Balego TENS Digital Edition with Accessories for Pain Relief (OTC)NUH · Special | Everyway Medical Instruments Co., Ldt. | 06/06/2018SE |
| K172919 | EV-804 OTC Pain Relief TENSNUH · Traditional | Everyway Medical Instruments Co.,Ltd | 04/19/2018SE |
| K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)NUH · Traditional | Bayer Healthcare, LLC | 03/07/2018SE |
| K173462 | Wireless Pain Relieve Device Model: LT5018CNUH · Special | Shenzhen Dongdixin Technology Co., Ltd. | 12/08/2017SE |
| K171803 | HIVOX OTC Electrical StimulatorNUH · Traditional | Hivox Biotek, Inc. | 11/29/2017SE |
| K172451 | Dr.MUSIC 3sNUH · Traditional | Smartmedicaldevice Co., Ltd. | 11/17/2017SE |
| K171026 | Mytens Model: BW-TSXNUH · Traditional | Bewell Connect Corp. | 11/01/2017SE |
| K172079 | AvailNUH · Traditional | Omron Healthcare, Inc. | 10/19/2017SE |
| K172809 | OTC Combo TENS/EMS SystemNUH · Special | Well-Life Healthcare Limited | 10/18/2017SE |
| K171599 | WiTouch Pro, WiTouch, NeubacNUH · Traditional | Hollywog, LLC | 09/22/2017SE |
| K163611 | Pain Therapy DeviceNUH · Traditional | Guangzhou Xinbo Electronic Co., Ltd. | 09/19/2017SE |
| K163166 | EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS onlyNUH · Traditional | Easywell Biomedicals, Inc. | 08/11/2017SE |
| K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N)NUH · Traditional | Hi-Dow International, Inc. | 08/04/2017SE |
| K163153 | LiviaNUH · Traditional | Lifecare , Ltd. | 06/28/2017SE |
| K170659 | IQ TechnologiesNUH · Special | Iq Technologies, Inc. | 05/26/2017SE |
| K162392 | AvazziaNUH · Traditional | Avazzia, Inc. | 05/12/2017SE |
| K170205 | Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203NUH · Traditional | Shenzhen Kentro Medical Electronics Co., Ltd. | 05/11/2017SE |
| K170145 | Digital TENS UnitNUH · Traditional | Shenzhen Eapply Technology Co., Ltd. | 04/29/2017SE |
| K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13NUH · Traditional | Jkh Health Co., Ltd. | 04/14/2017SE |
| K162479 | Smart Pain Reliever, Model LT5019NUH · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 02/08/2017SE |
| K162630 | CP Relief Wand-OTCNUH · Traditional | Mid-America Medical Innovations, LLC | 12/20/2016SE |
| K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605ANUH · Traditional | Well-Life Healthcare Limited | 12/05/2016SE |
| K160508 | Electronic Pulse StimulatorNUH · Traditional | Beijing Choice Electronic Technololgy Co., Ltd. | 11/21/2016SE |
| K161537 | OTC TENS Device, Model PTS-IVNUH · Traditional | Counter Scientific Development (Gz), Ltd. | 10/13/2016SE |
| K151995 | Painmaster MCT PatchNUH · Traditional | Newmark, Inc. | 10/05/2016SE |
| K160255 | HBOTC Muscle and Nerve StimulatorNUH · Traditional | Hb Medical, Inc. | 09/15/2016SE |
| K160893 | HANAROCare ReJuNUH · Traditional | M.I.Tech Co., Ltd. | 07/27/2016SE |
| K160115 | Heat Pain ProNUH · Traditional | Omron Healthcare, Inc. | 06/03/2016SE |
| K160052 | CUR Model 1NUH · Traditional | Thimble Bioelectronics, Inc. | 05/20/2016SE |
| K153520 | Electronic Pulse StimulatorNUH · Traditional | Jkh Health Co., Ltd. | 05/05/2016SE |
| K150277 | Pain Therapy System, Model PTS-IINUH · Traditional | Counter Scientific Development (Gz), Ltd. | 02/12/2016SE |
| K152374 | LL TENS 160A, LL TENS 160BNUH · Traditional | Fuji Dynamics , Ltd. | 01/13/2016SE |
| K152954 | QuellNUH · Traditional | Neurometrix, Inc. | 01/05/2016SE |
| K152128 | 2-in-1 Abdominal Muscle Training & Back Pain Relief SystemNUH · Traditional | Tohkai Precision Electrical Manufactory… | 12/23/2015SE |
| K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)NUH · Traditional | Bayer Healthcare, LLC | 12/22/2015SE |
| K151279 | Counter OTC TENS Device, Model CSD-737ZNUH · Traditional | Counter Scientific Development (Gz), Ltd. | 12/16/2015SE |
| K151034 | PainKARENUH · Traditional | Triowave Technologies | 11/21/2015SE |
| K150386 | Tyece OTC TENS DeviceNUH · Traditional | Tyece , Ltd. | 11/05/2015SE |
| K150308 | Palm TENSNUH · Traditional | Heat IN A Click, LLC | 10/20/2015SE |
| K151479 | EV-820 OTC Pain Relief TENSNUH · Traditional | Everyway Medical Instruments Co.,Ltd | 10/16/2015SE |
| K150043 | Transcutaneous Electrical Nerve Stimulators (TENS)NUH · Traditional | Andon Health Co, Ltd. | 08/14/2015SE |
| K151035 | PulseReliefNUH · Traditional | Philips Consumer Lifestyle | 07/21/2015SE |
| K143268 | TENS and Powered Muscle StimulatorNUH · Traditional | Shenzhen As-Tec Technology Co., Ltd. | 07/21/2015SE |
| K150995 | Electronic Pulse StimulatorNUH · Traditional | Shenzhen Jingkehui Electronic Co.., Ltd. | 07/06/2015SE |
| K143430 | SmartTENSNUH · Abbreviated | Easy Med Instrument Co., Ltd. | 05/29/2015SE |
| K150681 | Gemore OTC TENSNUH · Traditional | Gemore Technology Co, Ltd. | 05/12/2015SE |
| K133789 | Dolphin Neurostim OTCNUH · Traditional | Acumed Medical , Ltd. | 03/04/2015SE |
| K142686 | StimPad OTCNUH · Traditional | Aemed, Inc. | 12/18/2014SE |
| K141978 | Maxpower ReliefNUH · Traditional | Omron Healthcare, Inc. | 12/03/2014SE |
| K133502 | 5000Z Firefly SystemNUH · Special | Prizm Medical, Inc. | 12/03/2014SE |
| K141299 | OTC Combo Tens/Ems SystemNUH · Traditional | Well-Life Healthcare Limited | 11/14/2014SE |
| K133929 | Health Expert Elctronic StimulatorNUH · Traditional | Shenzhen Osto Technology Company Limited | 11/12/2014SE |
| K141260 | Electronic Pulse StimulatorNUH · Traditional | Shenzhen Jingkehui Electronic Co.., Ltd. | 09/17/2014SE |
| K140168 | Easystim TN28_OTCNUH · Traditional | Easymed Instruments Co., Ltd. | 08/28/2014SE |
| K133979 | TENSNUH · Traditional | Sunmas (H.K.) Trading Limited | 08/26/2014SE |
| K131290 | Iq TechnologiesNUH · Traditional | Iq Technologies, Inc. | 08/06/2014SE |
| K140333 | AscendNUH · Traditional | Neurometrix, Inc. | 07/03/2014SE |
| K140650 | Hivox Electric Stimulator OTC TENSNUH · Traditional | Hivox Biotek, Inc. | 06/27/2014SE |
| K132993 | Counter OTC TENS DeviceNUH · Traditional | Counter Scientific Development (Gz), Ltd. | 04/24/2014SE |
| K132563 | Pinook StimulatorNUH · Traditional | Pinook USA | 04/24/2014SE |
| K131956 | Quick Relax ProNUH · Traditional | Healthcare Innovations, LLC | 04/24/2014SE |
| K133723 | OTC PatchNUH · Abbreviated | Well-Life Healthcare Limited | 01/28/2014SE |
| K131910 | MPPNUH · Traditional | Marc Pro | 01/24/2014SE |
| K131933 | Electronic Pulse MassagerNUH · Traditional | Gurin Products, LLC | 12/20/2013SE |
| K131921 | Electronic Pulse StimulatorNUH · Traditional | Shenzhen Jingkehui Electronic Co.., Ltd. | 11/15/2013SE |
| K122410 | I Rune (I-200L)NUH · Traditional | Medirune Co, Ltd. | 11/12/2013SE |